Bleeding is one of the potentially dangerous and common complications in patients with acute and chronic renal failure .Bleeding from uremia is multifactorial. Impaired function of the interaction between platelets and platelets together with the vessel wall, due to the toxicity of urea in the blood, has an important role in causing the bleeding. Crayoprcipitate and estrogen conjugate in the treatment of bleeding are used.
In this study the effect of estrogen in the prevention of bleeding in this patients compared with crayoprcipitate .This study initialy intends complications and benefits oral estrogen compared with crayoprcipitate transfusion.
In a clinical trial, the number of 30 patients with renal failure who admitted in nephrology ward and all of them candidates for biopsy selected. patients divided two groups
1)Infusion of 10 units crayoprcipitate in the morning of biopsy
2) 1.25mg estrogen TID administered than 5 days before biopsy
Then each group controlled hemorrhagic complications (vital signs, hemoglobin level, hematuria sonographic control of hematoma) in the same day and the next day after the biopsy .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201028593N1
Registration date:2012-01-19, 1390/10/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-19, 1390/10/29
Registrant information
Name
Kaveh Ebadiborna
Name of organization / entity
jondishapour university
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 8781
Email address
ebadiborna.k@ajmus.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapour of Medical Science
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral conjugated estrogen compared with cryoprecipitate to prevent bleeding in patients with renal failure candidates for kidney biopsy
Public title
Effects of oral conjugated estrogen in preventing bleeding from renal biopsy in uremic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with renal insufficiency (creatinine greater than 3 mg/dL) who are candidates for biopsy
Exclusion criteria:
1.Pregnant women, or women who suspect pregnancy and ways to avoid becoming pregnant to leave have
2.Lactating women
3.Patients with a history of thromboembolism
4.Any of the patients treated with anticoagulant or platelet aggregation inhibitors such as warfarin, heparin, enoxaparin, Ticlopidine, clopidogrel, and statins and their agents can not be stopped
5.Patients who are treated with NSAIDs and their agents can not be interrupted for any reason
6.Patientswho have clotting disorders (such as patients with hemophilia) or in the laboratory of PT> 14, PTT> 35, or INR> 1.5
7.Patients who were under a regime of hard power (such as prolonged fasting or water treatment) and lack of essential Elements, vitamins such as vitamin C or K in the body there
8.Patients who have blood pressure higher than 160/100,before the biopsy
9.Patients with a creatinine level is less than 3 milligrams per deciliter
10.Patients who are suffering from liver cirrhosis.
11.Patients with platelet count less than 100,000
12.Patients who have cysts in both kidney
13.Patients who have undergone kidney transplant
14.Patients who are diagnosed with breast cancer
15.Patients who have a history of stroke and myocardial infarction
16.Patients who are unexplained uterine bleeding
17.Patients who have a history of sensitivity to estrogen compounds
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jondishapour of Medical Science
Street address
University City,Ahvaz
City
Ahvaz
Postal code
15749-61357
Approval date
2011-10-15, 1390/07/23
Ethics committee reference number
ETH-244
Health conditions studied
1
Description of health condition studied
Renal failure
ICD-10 code
N17.9
ICD-10 code description
Acute renal failure, unspecified
Primary outcomes
1
Description
Hemodynamic change
Timepoint
Day of biopsy and next day
Method of measurement
Blood pressure and pulse rate control and orthostatic change
2
Description
Hemoglobin level
Timepoint
One day before biopsy and every 8 time after biopsy for 24 hour
Method of measurement
Hemoglobin level control
3
Description
Hematuria
Timepoint
Day of biopsy and next day
Method of measurement
Urine Analysis
4
Description
Biopsy site hematoma
Timepoint
Day of biopsy and next day
Method of measurement
Ultrasound
5
Description
Bleeding Time
Timepoint
Day of biopsy and next day
Method of measurement
Bleeding Time test with lancet
Secondary outcomes
1
Description
Major bleeding
Timepoint
Day of biopsy and next day
Method of measurement
Hemodynamic change,The need for blood transfusion,Surgery
Intervention groups
1
Description
10 unit crayopercipitat transfusion on day of biopsy in group 1
Category
Prevention
2
Description
Oral administration of conjugated estrogen 1.25 mg every 8 hours for 5 days before biopsy in Group 2
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital Nephrology ward
Full name of responsible person
kaveh ebadi borna
Street address
Golestan haospital Ahvaz
City
Ahvaz
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Nephrology Ward
Full name of responsible person
kaveh ebadi borna
Street address
Imam hospital Azadegan Ave. Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Ahvaz University of Medical Science and Health science
Full name of responsible person
Dr.mostafa Feghi
Street address
University City,Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Ahvaz University of Medical Science and Health science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Science and Health Science